Drug recall
12.5% Minoxidil Solution, 125 mL bottle, Rx, Compounded for Regrowth, LLC, 7049 Greenleaf Avenue, Whittier, CA…
FDA recall event 58745 · Class II · Re Growth Llc
Key facts
| Event ID | 58745 |
|---|---|
| Recall numbers | D-513-2011, D-514-2011, D-515-2011, D-516-2011, D-517-2011, D-518-2011, D-519-2011, D-520-2011, D-521-2011, D-522-2011, D-523-2011, D-524-2011 and 4 more |
| Recalling firm | Re Growth Llc |
| Product type | Drugs |
| Products | 12.5% Minoxidil Solution, 125 mL bottle, Rx, Compounded for Regrowth, LLC, 7049 Greenleaf Avenue, Whittier, CA 90602, 2% Spironolactone Topical Solution, 60 mL bottle, Rx, Compounded for Regrowth, Llc, 7049 Greenleaf Avenue, Whittier, CA 90602, USA, 5% Spironolactone Lotion, 2 oz jar, Rx, Compounded for Regrowth, LLC, 7049 Greenleaf Avenue, Whittier, CA 90602, USA, 6% Minoxidil Plus Solution, 65ml bottle, Rx, Compounded for Regrowth, LLC, 7049 Greenleaf Avenue, Whittier, CA 90602, Minoxidil 5% Topical Solution, 65ml bottle, Rx, Compounded for Regrowth, LLC, 7049 Greenleaf Avenue, Whittier, CA 90602 and 11 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Marketed Without an Approved NDA/ANDA: These products are unapproved drugs and may present potential health hazards. |
| Initiation date | Feb 24, 2011 |
| Termination date | Oct 18, 2013 |
| City | Whittier |
| State | CA |
| Country | United States |
| FEI number | 3006125007 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports